COhort of antithrOmbotic Use and cLinical Outcomes in Patients With Atrial Fibrillation (COOL-AF) Phase 2

Recruiting now

Conditions studied: Atrial Fibrillation

In brief

Atrial fibrillation (AF) is a leading cause of cardiovascular mortality and morbidity. Asian patients with AF have a higher rate of major bleeding including intracranial hemorrhage (ICH) compared to non-Asians. Non-vitamin K antagonist oral anticoagulants (NOACs) are the safer drugs compared to warfarin due to a lower rate of ICH, but the rate of NOACs use in many Asian AF is much lower than non-Asian countries due to economic concerns. The purpose of the COhort of antithrOmbotic use and cLinical outcomes in patients with Atrial Fibrillation (COOL-AF) Phase 2 registry is to determine the changes in antithrombotic patterns and the impact on clinical outcomes. The COOL-AF Phase 2 study is a prospective observational multicenter study of patients with known or newly diagnosed non-valvular AF in Thailand. The aim is a sample size is 3680 patients from 33 centers within a 2-years enrollment timeline. Patients will be follow-up every 6 months until 3 years. The study outcomes were death, ischemic stroke/systemic embolism, major bleeding, myocardial infarction, heart failure, and quality of life.

Key facts

Study ID

NCT06396299

Run by

Mahidol University

People needed

4000

Starts

2024-06-02

Expected to finish

2030-06-01

Last updated by the study team

2025-05-09

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants aged 18 years and older with atrial fibrillation diagnosed based on a 12-lead ECG or ECG tracing from ambulatory ECG monitoring.

You may not qualify if…

• Patients who have experienced an ischemic stroke within the past 3 months before enrollment.
• Patients with a platelet count less than 100,000/mm3 or who have myeloproliferative disorders (essential thrombocythemia, chronic myeloid leukemia, polycythemia vera, agnogenic myeloid metaplasia), hyperviscosity syndrome, chronic disseminated intravascular coagulation (DIC), or antiphospholipid syndrome.
• Patients with a mechanical prosthetic heart valve.
• Patients with rheumatic mitral stenosis.
• Patients participating in research projects with concealed treatments.
• Patients expected to have a life expectancy of less than 3 years due to other diseases, such as cancer or AIDS, as determined from medical records.
• Pregnancy.
• Patients unable to follow the treatment plan.
• Patients who do not consent to participate in the study.
• Patients who are hospitalized or discharged from the hospital within the past 1 month.Contact/Locations

Where it is running

• Faculty of Medicine, Chiang Mai University, — Chiang Mai, Chiang Mai, Thailand (enrolling)
• Bhumibol Adulyadej Hospital — Bangkok, Thailand (enrolling)
• Charoen Krung Pracha Rak Hospital — Bangkok, Thailand (enrolling)
• Vachira Phuket Hospital — Phuket, Thailand (enrolling)
• Ratchaburi Hospital — Ratchaburi, Thailand (enrolling)
• Suratthani Hospital — Surat Thani, Thailand (enrolling)
• Surin Hospital — Surin, Thailand (enrolling)
• Sunpasitthiprasong Hospital — Ubon Ratchathani, Thailand (enrolling)
• Udonthani Hospital — Udon Thani, Thailand (enrolling)
• Faculty of Meddcine Siriraj Hospital, Mahidol University — Bangkok, Bangkok, Thailand (enrolling)
• Faculty of Medicine, Chulalongkorn University, — Bangkok, Bangkok, Thailand (enrolling)
• Faculty of Medicine, Ramathibodi Hospital, Mahidol University — Bangkok, Bangkok, Thailand (enrolling)
• Faculty of Medicine, Vajira Hospital, Navamindradhiraj University — Bangkok, Bangkok, Thailand (enrolling)
• Central Chest Institute of Thailand — Nonthaburi, Changwat Nonthaburi, Thailand (enrolling)
• Faculty of Medicine, Prince of Songkla University — Songkhla, Changwat Songkhla, Thailand (enrolling)
• Chonburi Hospital — Chon Buri, Thailand (enrolling)
• Queen Savang Vadhana Memorial Hospital — Chon Buri, Thailand (enrolling)
• Faculty of Medicine, Khon Kaen University — Khon Kaen, Thailand (enrolling)
• Maharat Nakorn Ratchasima Hospital — Nakhon Ratchasima, Thailand (enrolling)
• Sawanpracharak Hospital — Nakhon Sawan, Thailand (enrolling)
• Faculty of Medicine, Thammasat University, Rangsit Campus — Pathum Thani, Thailand (enrolling)
• Rajavithi Hospital — Bangkok, Thailand
• Prapokklao Hospital (Chanthaburi), — Chanthaburi, Thailand
• Nakornping Hospital — Chiang Mai, Thailand
• Chiangrai Prachanukroh Hospital — Chiang Rai, Thailand

Full record on ClinicalTrials.gov

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